Prospective Evaluation of the Efficacy and Safety of Submucosal Endoscopy

Gastroparesis Clinical Trial

Official title:

Prospective Evaluation of the Efficacy and Safety of Submucosal Endoscopy

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03626350
• Other study ID #: 18-0046
• Status: Active, not recruiting
• Start date: June 12, 2018
• Est. completion date: June 12, 2025

Study information

• Verified date: May 2024
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

To test the idea that submucosal endoscopy is effective and safe for endoscopic myotomy, endoscopic submucosal dissection, and access for tissue acquisition and resection. Submucosal endoscopy is a recent innovative addition to gastrointestinal endoscopy. This involves endoscopic maneuvers in the gut wall, by dissection of the submucosal layer of GI tract, thereby allowing endoscopic myotomy (incision of the muscle), endoscopic access for tissue acquisition and therapy, and resection of precancerous and cancerous gastrointestinal tissue. This approach has been a dramatic game-changer for minimally invasive management of various gastrointestinal conditions such as Zenker's diverticulum, Achalasia, Spastic Esophageal Disorders, Gastroparesis, esophageal obstruction, Hirschsprung's Disease, and Gastrointestinal neoplasia. The aim of the proposed study is to prospectively assess technical success, clinical success, and adverse events after submucosal endoscopy. Technical success will be defined as ability to successfully complete the submucosal endoscopic procedure. Clinical success will be defined as symptom relief and objective evaluation which will be assessed with radiologic imaging, repeat endoscopy, gastrointestinal motility studies, and pathology results routinely performed post-procedure for clinical care, as indicated. Adverse events will be recorded per published ASGE criteria. A database/ registry of patients undergoing submucosal endoscopic procedures will be created to demonstrate this.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 250
• Est. completion date: June 12, 2025
• Est. primary completion date: June 12, 2025
• Gender: All
• Age group: 18 Years to 89 Years

Eligibility

Inclusion Criteria:

1. Patients who will undergo submucosal endoscopy

2. Age >18 years

Exclusion Criteria:

1. Age <18 years

2. Pregnancy

3. Coagulopathy (platelets less than 50, INR more than 1.8)

Related Conditions & MeSH terms

• Diverticulum
• Esophageal Diseases
• Esophageal Obstruction
• Gastrointestinal Neoplasia
• Gastroparesis
• Hirschsprung Disease
• Hirschsprung's Disease
• Spastic Esophageal Disorders
• Zenker Diverticulum
• Zenker's Diverticulum

Locations

Country	Name	City	State
United States	University of Colorado Hospital	Aurora	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
University of Colorado, Denver

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Technical and clinical success in performing submucosal endoscopy	Improvement in symptoms and objectively assessed by radiologic imaging, repeat endoscopy, gastrointestinal motility studies, and pathology.	baseline to one year
Primary	Adverse Events	as defined by published ASGE criteria	baseline to one year
Secondary	Procedure time	Procedure time	During procedure
Secondary	Submucosal endoscopy technique and device used	Submucosal endoscopy technique and device used	During procedure